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510(k) K895502

MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT by Microbio-Medics, Inc. — Product Code EPP

K895502 is an FDA 510(k) premarket notification submitted by Microbio-Medics, Inc. for the device "MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT". The FDA issued a decision of Substantially Equivalent on December 8, 1989. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Microbio-Medics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1989
Date Received
September 12, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Nasal
Device Class
Class I
Regulation Number
874.5800
Review Panel
EN
Submission Type

Other clearances by Microbio-Medics, Inc.

  • K923353 — VENTILATION TUBES W/ HYDROGEL COATING (May 18, 1993)
  • K922572 — 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR (November 2, 1992)
  • K913276 — MICROTEK MEDICAL'S SOUND STIKS (October 21, 1991)
  • K904239 — SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES (June 21, 1991)
  • K910167 — MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM (April 15, 1991)
  • K900726 — MICROTEK MEDICAL'S BLOOD COLLECTION KIT (May 4, 1990)
  • K901154 — MICROTEK'S SURGICAL LAMP HANDLE & COVER (March 20, 1990)
  • K895814 — MICROTEK PISTON & WIRE PROSTHESES (December 26, 1989)
  • K895815 — MICROTEK TOTAL OSSICULAR PROTHESIS (December 26, 1989)
  • K885201 — OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT (April 19, 1989)

Other clearances for product code EPP

  • K942158 — AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (July 29, 1994)
  • K942724 — EXTERNAL NASAL SPLINT (July 8, 1994)
  • K890599 — HOOD NASAL SPLINT (March 17, 1989)
  • K882244 — RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT (June 23, 1988)
  • K872905 — AMERICAN NASAL SPONGE (September 4, 1987)
  • K864930 — 'EXMOOR' ATKINS NASAL SPLINT (March 4, 1987)
  • K864933 — 'EXMOOR' SHAH & MACKAY NASAL SPLINTS (March 4, 1987)
  • K864932 — 'EXMOOR' CAWOOD NASAL SPLINTS (March 4, 1987)
  • K864934 — 'EXMOOR' SHAH SILICONE DISCS (January 28, 1987)
  • K863382 — CANNON NASAL SPLINT (October 7, 1986)

FDA data resources